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Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer

Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Head and Neck Cancer

Intervention: Valproic Acid (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: University of California, San Francisco

Official(s) and/or principal investigator(s):
Electron Kebebew, MD, Principal Investigator, Affiliation: University of California, San Francisco

Summary

RATIONALE: Drugs such as valproic acid may make thyroid cancers more radioiodine sensitive, which will allow for detection of tumor and make further ablation treatment effective.

Clinical Details

Official title: A Phase II Trial of Valproic Acid (Depakote ER ) in Patients With Advanced Thyroid Cancers of Follicular Origin, Who Are Thyroglobulin Positive/RAI Unresponsive

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Decrease in Thyroglobulin Level

Decrease in Tumor Size

Secondary outcome:

Increased Radioactive Iodine Uptake

Side Effects of Drugs Affecting Quality of Life

Survival

Detailed description: PURPOSE: This phase II trial is studying how well valproic acid works in treating patients with thyroid cancers that do not respond well to other treatments.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

INCLUSION CRITERIA: DISEASE CHARACTERISTICS

- Diagnosis of advanced/poorly differentiated thyroid cancer of follicular cell origin

that is radioiodine-unresponsive

- Cumulative dose of radioiodine < 800 mCi

- No radioiodine uptake on whole body scan within 18 months of enrollment

- Inoperable extensive locoregional tumor mass and/or metastatic spread

- Failed conventional therapy that included total thyroidectomy AND radioactive iodine

I 131 ablation

- Elevated thyroglobulin level (>2ng/ml on thyroid hormone, >10ng/ml off thyroid

hormone)or Tg-antibody positive PATIENT CHARACTERISTICS

- 18 years or older

Entry lab results:

- Hemoglobin > 8. 0 gm/dl

- Absolute Neutrophil Count > 750 cells/mm3

- Platelet count > 75000/mm3

- BUN < 1. 5 times upper limit of normal (ULN)

- Creatinine < 1. 5 times ULN

- Total protein > 6. 4

- Total bilirubin should be < 1. 5 times ULN.

- AST (SGOT), ALT (SGPT), ALKP and amylase < 1. 5 times ULN

- Amylase < 1. 5 times ULN

- Albumin > 2. 5

- Ammonia < 1. 5 times ULN

EXCLUSION CRITERIA:

- Not pregnant

- No nursing within the past 3 months

- No allergy to valproic acid

- No coexisting malignancy other than basal cell carcinoma

- No hepatic disease or significant dysfunction

- Karnofsky score > 80

- No pancreatitis

- No kidney dysfunction

- Fertile patients must use effective contraception

Locations and Contacts

UCSF Comprehensive Cancer Center, San Francisco, California 94115, United States
Additional Information

Starting date: August 2007
Last updated: January 21, 2015

Page last updated: August 23, 2015

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